{"id":"mycophenolate-mofetil-tab-cap","safety":{"commonSideEffects":[{"rate":"19-45","effect":"Diarrhea"},{"rate":"13-45","effect":"Leukopenia"},{"rate":"8-26","effect":"Anemia"},{"rate":"20-27","effect":"Infection"},{"rate":"11-36","effect":"Nausea"},{"rate":"9-19","effect":"Vomiting"},{"rate":"12-19","effect":"Abdominal pain"},{"rate":"5-12","effect":"Tremor"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Mycophenolate mofetil is rapidly converted to mycophenolic acid (MPA), its active form, which preferentially inhibits IMPDH type II, an enzyme critical for guanosine nucleotide synthesis in lymphocytes. By depleting guanosine nucleotides, MPA selectively suppresses the proliferation of T and B cells while having minimal effects on other cell types, making it an effective immunosuppressant. This mechanism makes it particularly useful in preventing organ rejection and treating autoimmune conditions.","oneSentence":"Mycophenolate mofetil is a prodrug that inhibits inosine monophosphate dehydrogenase (IMPDH), selectively suppressing T and B lymphocyte proliferation.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:56:17.778Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of organ rejection in renal, cardiac, and hepatic transplant recipients"},{"name":"Active lupus nephritis"},{"name":"Active rheumatoid arthritis (as adjunctive therapy)"}]},"trialDetails":[{"nctId":"NCT05193565","phase":"PHASE4","title":"Study to Compare the Efficacy and Safety After Conversion to RaparoBell® or My-Rept® in Kidney Transplant Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"Chong Kun Dang Pharmaceutical","startDate":"2021-11-19","conditions":"Kidney Transplantation","enrollment":206},{"nctId":"NCT03983850","phase":"PHASE1, PHASE2","title":"Optimizing PTCy Dose and Timing","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2019-07-09","conditions":"Graft Versus Host Disease, Hematologic Neoplasms","enrollment":105},{"nctId":"NCT03841097","phase":"PHASE4","title":"Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Transplants","status":"ACTIVE_NOT_RECRUITING","sponsor":"Roy D. Bloom, MD","startDate":"2019-11-11","conditions":"Kidney Transplant; Complications","enrollment":60},{"nctId":"NCT01282073","phase":"PHASE3","title":"Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy","status":"COMPLETED","sponsor":"Kyungpook National University Hospital","startDate":"2011-03","conditions":"Glomerulonephritis, Membranous","enrollment":43},{"nctId":"NCT06942156","phase":"PHASE4","title":"Optimize Immunosuppressive Therapy Using Everolimus and Low-dose Calcineurin Inhibitors in Heart Transplant Patients in Korea","status":"NOT_YET_RECRUITING","sponsor":"Chong Kun Dang Pharmaceutical","startDate":"2025-08-14","conditions":"Heart Transplant","enrollment":140},{"nctId":"NCT00866684","phase":"PHASE4","title":"Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol","status":"TERMINATED","sponsor":"Charite University, Berlin, Germany","startDate":"2007-01-01","conditions":"Skin Cancer","enrollment":44},{"nctId":"NCT06044493","phase":"PHASE4","title":"MYREPTIC-N® or MY-REPT® in Stable Patients After Kidney Transplant Recipients","status":"RECRUITING","sponsor":"Chong Kun Dang Pharmaceutical","startDate":"2023-11-15","conditions":"Kidney Transplant","enrollment":158},{"nctId":"NCT02921789","phase":"PHASE2","title":"Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients","status":"COMPLETED","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2017-05-22","conditions":"Kidney Transplantation, Primary Focal Segmental Glomerulosclerosis (FSGS)","enrollment":67},{"nctId":"NCT03794492","phase":"PHASE4","title":"Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome","status":"COMPLETED","sponsor":"Chong Kun Dang Pharmaceutical","startDate":"2018-03-31","conditions":"Kidney Transplant","enrollment":169},{"nctId":"NCT04207177","phase":"PHASE4","title":"Immunosuppressive Drugs and Gut Microbiome: Pharmacokinetic- and Microbiome Diversity Effects","status":"ACTIVE_NOT_RECRUITING","sponsor":"Oslo University Hospital","startDate":"2019-10-30","conditions":"Kidney Transplant; Complications, Immune Suppression","enrollment":100},{"nctId":"NCT03386539","phase":"PHASE3","title":"Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score","status":"UNKNOWN","sponsor":"Boston Children's Hospital","startDate":"2018-01-29","conditions":"Pediatric Heart Transplantation, Immunosuppression, Chronic Kidney Diseases","enrollment":211},{"nctId":"NCT04048161","phase":"PHASE4","title":"Study of Tacrolimus vs Mycophenolate Mofetil in Pediatric Patients With Nephrotic Syndrome","status":"COMPLETED","sponsor":"The Children's Hospital of Zhejiang University School of Medicine","startDate":"2019-11-12","conditions":"Nephrotic Syndrome in Children","enrollment":270},{"nctId":"NCT05202145","phase":"PHASE1","title":"Drug-Drug Interaction (DDI) Study of ALXN2050 in Healthy Adult Participants","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2022-01-11","conditions":"Healthy","enrollment":61},{"nctId":"NCT03099122","phase":"PHASE4","title":"A Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant","status":"COMPLETED","sponsor":"Sanofi","startDate":"2017-08-16","conditions":"End-stage Renal Disease","enrollment":115},{"nctId":"NCT01085097","phase":"PHASE2","title":"A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis","status":"COMPLETED","sponsor":"Teva Branded Pharmaceutical Products R&D, Inc.","startDate":"2010-09-01","conditions":"Lupus Nephritis","enrollment":46},{"nctId":"NCT04700709","phase":"PHASE4","title":"Efficacy and Safety of Sirolimus Plus CNI Compared With MMF Plus CNI in ABO-i Kidney Transplant Recipients.","status":"UNKNOWN","sponsor":"Chong Kun Dang Pharmaceutical","startDate":"2021-01","conditions":"Kidney Transplantation","enrollment":158},{"nctId":"NCT04471441","phase":"PHASE4","title":"Efficacy and Safety of Everolimus Versus Mycophenolate Mofetil in Liver Transplant Recipients.","status":"UNKNOWN","sponsor":"Chong Kun Dang Pharmaceutical","startDate":"2020-06-30","conditions":"Liver Transplant","enrollment":150},{"nctId":"NCT03828682","phase":"PHASE4","title":"Veloxis de Novo Kidney Transplant ECSWD","status":"UNKNOWN","sponsor":"Simon Tremblay, PharmD, PhD","startDate":"2019-06-21","conditions":"Kidney Transplantation, Immunosuppression","enrollment":60},{"nctId":"NCT02432339","phase":"PHASE1, PHASE2","title":"Effects of an Immunosuppressant Mycophenolate Mofetil or MMF on the Urinary Sodium Excretion Response to Mental Stress","status":"UNKNOWN","sponsor":"Augusta University","startDate":"2014-04-22","conditions":"Psychological Stress, Hypertension, Renal","enrollment":50},{"nctId":"NCT00862979","phase":"PHASE4","title":"A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2009-02-24","conditions":"Heart Transplantation","enrollment":162},{"nctId":"NCT01895894","phase":"PHASE4","title":"Mycophenolate Mofetil in Pediatric Steroid Dependent Nephrotic Syndrome","status":"COMPLETED","sponsor":"Seoul National University Hospital","startDate":"2013-09","conditions":"Nephrotic Syndrome","enrollment":34},{"nctId":"NCT01410448","phase":"PHASE3","title":"Everolimus in de Novo Kidney Transplant Recipients","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2011-11","conditions":"Kidney Transplantation","enrollment":383},{"nctId":"NCT01843348","phase":"PHASE3","title":"12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2012-12-27","conditions":"Kidney Transplantation, Renal Transplantation","enrollment":612},{"nctId":"NCT00239005","phase":"PHASE4","title":"Enteric-Coated Mycophenolate Sodium on Quality of Life in Patients With Gastrointestinal Symptoms Related to Mycophenolate Mofetil Therapy After Kidney Transplantation","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2005-09","conditions":"Renal Transplant","enrollment":134},{"nctId":"NCT02949349","phase":"PHASE2","title":"Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis","status":"COMPLETED","sponsor":"Genovate Biotechnology Co., Ltd.,","startDate":"2015-07","conditions":"Lupus Nephritis","enrollment":32},{"nctId":"NCT00514514","phase":"PHASE3","title":"Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Calcineurin Inhibitor (CNI)-Free Regimen and a CNI-low Dose Regimen","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2007-07","conditions":"Kidney Transplantation","enrollment":802},{"nctId":"NCT00087581","phase":"PHASE4","title":"Study of Therapeutic Monitoring of Mycophenolate Mofetil (MMF/CellCept) After Kidney Transplantation","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2004-06","conditions":"Kidney Transplantation","enrollment":720},{"nctId":"NCT01187953","phase":"PHASE3","title":"Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx","status":"COMPLETED","sponsor":"Veloxis Pharmaceuticals","startDate":"2010-09","conditions":"Renal Failure","enrollment":543},{"nctId":"NCT02686619","phase":"PHASE3","title":"Study Comparing Efficacy and Safety of Mycophenolate Mofetil (Cellcept) With Delayed Introduction of Sirolimus and Discontinuation of Cyclosporine, With Those of Mycophenolate Mofetil and Long Term Continuation of Cyclosporine in Renal Transplant Recipients","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2004-11","conditions":"Renal Transplantation","enrollment":237},{"nctId":"NCT01025817","phase":"PHASE3","title":"Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2010-01","conditions":"Kidney Transplant","enrollment":613},{"nctId":"NCT01842269","phase":"PHASE4","title":"Evaluate the Efficacy and Safety of My-Rept® Tablet vs. My-Rept® Capsule in Combination With Tacrolimus in Kidney Transplant Patients","status":"COMPLETED","sponsor":"Chong Kun Dang Pharmaceutical","startDate":"2013-01","conditions":"Kidney Transplantation","enrollment":156},{"nctId":"NCT00965094","phase":"PHASE4","title":"Efficacy and Safety of Everolimus+EC-MPS After Early CNI Elimination vs EC-MPS +Tacrolimus in Renal Transplant Recipients","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2009-12","conditions":"Chronic Renal Failure","enrollment":36},{"nctId":"NCT01596062","phase":"PHASE2","title":"Pharmacodynamics, Efficacy and Safety of Basiliximab 40 or 80 mg in Combination With Ciclosporine Microemulsion or Everolimus, in Adult Low Risk de Novo Renal Transplant Recipients (IDEALE Study)","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2012-03","conditions":"Renal Transplantation","enrollment":16},{"nctId":"NCT01079143","phase":"PHASE3","title":"Progression of Renal Interstitial Fibrosis / Tubular Atrophy (IF/TA) According to Epithelial-mesenchymal Transition (EMT) and Immunosuppressive Regimen (Everolimus Based Versus CNI Based) in de Novo Renal Transplant Recipients","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2009-09","conditions":"Renal Interstitial Fibrosis","enrollment":194},{"nctId":"NCT00414128","phase":"PHASE2, PHASE3","title":"Clinical Trial of Mycophenolate Versus Cyclophosphamide in ANCA Vasculitis","status":"COMPLETED","sponsor":"Cambridge University Hospitals NHS Foundation Trust","startDate":"2007-03","conditions":"Vasculitis","enrollment":140},{"nctId":"NCT00377637","phase":"PHASE3","title":"A Study of Mycophenolate Mofetil (CellCept) in Management of Patients With Lupus Nephritis.","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2005-07","conditions":"Lupus Nephritis","enrollment":370},{"nctId":"NCT00400400","phase":"PHASE4","title":"Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2006-10","conditions":"Renal Transplantation","enrollment":400},{"nctId":"NCT01016626","phase":"PHASE1","title":"Study to Evaluate the Pharmacokinetic Characteristics of CKD-4101 (Mycophenolate Mofetil) Tablet","status":"COMPLETED","sponsor":"Chong Kun Dang Pharmaceutical","startDate":"2009-07","conditions":"Healthy","enrollment":28}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Mycophenolate mofetil Tab./Cap.","genericName":"Mycophenolate mofetil Tab./Cap.","companyName":"Chong Kun Dang Pharmaceutical","companyId":"chong-kun-dang-pharmaceutical","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Mycophenolate mofetil is a prodrug that inhibits inosine monophosphate dehydrogenase (IMPDH), selectively suppressing T and B lymphocyte proliferation to prevent organ rejection. Used for Prevention of organ rejection in patients receiving allogeneic renal, cardiac, or hepatic transplants, Treatment of active lupus nephritis.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}